BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 8711575 · Received June 19, 2019

    Report

    Report Number
    2939274-2019-58733
    Event Type
    Injury
    Date Received
    June 19, 2019
    Report Date
    May 23, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS AUTHOR; NO OTHER DETAILS AVAILABLE. LOSS OF ANATOMICAL ALIGNMENT AND SURGICAL/MEDICAL INTERVENTION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SPONSELLER, P. ET AL (2015), GROWING ROD AND VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB PERFORM DIFFERENTLY FOR IDIOPATHIC EARLY ONSET SCOLIOSIS AT 5-YEAR FOLLOW-UP , SPINE DEFORMITY: THE OFFICIAL JOURNAL OF THE SCOLIOSIS RESEARCH SOCIETY NOVEMBER 2015 VOLUME 3(6), PAGE 628 (USA). THIS STUDY AIMS TO COMPARE CLINICAL AND RADIOGRAPHIC RESULTS BETWEEN TWO FORMS OF DISTRACTION FOR IDIOPATHIC EARLY-ONSET SCOLIOSIS (IEOS): GROWING ROD (GR) AND VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR).A TOTAL OF 72 PATIENTS WITH IDIOPATHIC EARLY-ONSET SCOLIOSIS (IEOS) WERE INCLUDED IN THE STUDY. FIFTY (50) PATIENTS WITH A MEAN AGE OF 5.5 YRS AT SURGERY WERE TREATED WITH GROWING RODS (GR) AND TWENTY TWO (22) PATIENTS WITH A MEAN AGE OF 4.3YRS AT SURGERY WERE TREATED WITH VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR).THE MEAN FOLLOW-UP WAS 5 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: VEPTR GROUP: PATIENTS UNDERWENT MORE TOTAL PROCEDURES. LOSS OF ANATOMICAL ALIGNMENT. PATIENTS HAD A HIGHER INCIDENCE OF DEEP INFECTION. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506774 PROSTHESIS, RIB REPLACEMENT MDI WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention